MiniMed® 530G MMT-751NAH (UDI 00643169736078)Recalls & reported problems
Medtronic Minimed, Inc. · PUMP MMT-751NAH PRDGM V3.0 PK EN 1PRESS · Class 3
All models of MiniMed 530G (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is a MiniMed 530G insulin pump, an artificial pancreas system that delivers insulin and pauses delivery when blood sugar drops too low. The 48 reports filed between 2017 and 2020 mostly describe buttons and keypads sticking or not responding, pumps freezing or alarming, batteries draining faster than expected, and insulin delivery problems, alongside blood sugar running high or low. There are no deaths, 20 injuries, and 28 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 20
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00643169736078), received between Sep 13, 2017 and Apr 9, 2020 — classified as 20 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Program or Calibrate” (8 reports).
2 other recalls cover devices cleared under the same FDA submission (P120010); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem9
- Device Difficult to Program or Calibrate8
- Obstruction of Flow8
- No Apparent Adverse Event7
- Device Displays Incorrect Message5
- Patient Device Interaction Problem5
- Mechanical Problem4
- Appropriate Device Problem Term/Code Not Available3
Patient problems
- No Consequences Or Impact To Patient22
- Hyperglycemia18
- Hypoglycemia8
- Elevated Ketones/ Diabetic Ketoacidosis1
- Nausea1
- Syncope1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
InjuryApr 9, 2020Excess Flow or Over-Infusion; No Apparent Adverse Event; Excess Flow or Over-Infusion; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 47 MG/DL. THE CUSTOMER TREATED LOW BLOOD GLUCOSE VALUE WITH GLUCOSE FOOD. BASED ON CUSTOMER¿S REPORT CUSTOMER REPORTED THAT INSULIN PUMP HAD OVER DELIVERY. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS NORMAL. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF LOW BLOOD GLUCOSE. THE INSULIN PUMP AND RESERVOIR WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 9942263 ↗MalfunctionDec 11, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Mechanical Problem; Obstruction of Flow; Battery Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP RECEIVED MOTOR ERRORS ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT THE INSULIN PUMP RECEIVED NO DELIVERY ALERTS. CUSTOMER REPORTED THAT INSULIN PUMP BATTERY LIFE WAS DIMINISHED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9449919 ↗MalfunctionNov 22, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD A KEYPAD ANOMALY AND THE BUTTONS WERE HARD TO PRESS. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. CUSTOMER STATED THAT SHE HAD A CAR ACCIDENT AND KEYPAD ANOMALY COULD BE DUE TO PROBLEM WITH HER HAND. NO TROUBLESHOOTING WAS PERFORMED. INSULIN PUMP IS NOT EXPECTED TO RETURN FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9360585 ↗MalfunctionOct 3, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER'S FAMILY MEMBER REPORTED VIA PHONE CALL THAT THE CUSTOMER'S INSULIN PUMP HAD BUTTON ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE WAS 219 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT BUTTONS NOT RESPONDING SPECIFIC TO ACT BUTTON AND THE UP BUTTON WAS ALSO STARTING TO BE STICKING. THE CUSTOMER STATED THAT THE TIME WAS ADVANCING. THE CUSTOMER WAS ADVICE THE INSULIN PUMP WILL NEED TO BE REPLACED. ADVICE TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9150102 ↗MalfunctionSep 23, 2019Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem; Mechanical Problem; Device Difficult to Program or Calibrate; Battery Problem; Power Problem; Patient Device Interaction Problem; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD STICKY BUTTONS HAD TO PRESS TO GET RESPONSE MORE ON THE ACT AND ESC. THE CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER ALSO STATED THAT GEAR WAS WINDING SLOWER THAN BEFORE WHEN PRIMING AND BATTERY LIFE MUCH MORE DIMINISHED. THE CUSTOMER STATED THAT INSULIN PUMP HAD FAILED BATTERY ALARM AND SCRATCHES ON THE SCREEN. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS..
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9103404 ↗MalfunctionSep 9, 2019Visual Prompts will not Clear; No Apparent Adverse Event; Patient Device Interaction Problem; Visual Prompts will not Clear; No Apparent Adverse Event; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD FROZEN UP. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER CANNOT READ THE SCREEN AT TIMES AND HAD CRACK ON THE BATTERY HOUSING. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8975489 ↗MalfunctionSep 9, 2019Failure to Cycle; Detachment of Device or Device Component; Failure to Cycle; Detachment of Device or Device Component
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED COMPROMISED FORCE SENSOR SYSTEM. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 131 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP WAS LOOSED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8973583 ↗MalfunctionSep 9, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE BUTTONS HAD TO BE PRESSED HARDER OR MULTIPLE TIMES TO RESPOND. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8973501 ↗MalfunctionSep 3, 2019Device Difficult to Program or Calibrate; Obstruction of Flow; Device Difficult to Program or Calibrate; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP¿S BUTTON HAD HARD TO PRESS. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN. CUSTOMER REPORTED THAT INSULIN PUMP SLOWER DURING REWIND AND HAD UNEXPLAINED NO DELIVERY ALARM. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8954545 ↗MalfunctionJul 19, 2019Failure to Cycle; Mechanical Problem; Obstruction of Flow; Priming Problem; Failure to Cycle; Mechanical Problem; Obstruction of Flow; Priming Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN WAS SQUIRTING OUT DURING PRIMING AND GRINDING DURING REWIND. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. THE CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP RECEIVED UNEXPLAINED NO DELIVERY ALARMS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8805905 ↗InjuryJul 18, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF BELOW 20 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FAINTING. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER WAS ALLEGING PUMP OVER DELIVERY DUE TO UNEXPLAINED LOWS. TROUBLESHOOTING WAS NOT COMPLETED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia; Syncope
MAUDE report 8805584 ↗MalfunctionJun 28, 2019No Display/Image; Power Problem; Patient Device Interaction Problem; No Display/Image; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP WAS TURNING ON AFTER CHANGING NEW BATTERIES. BLOOD GLUCOSE WAS 63 MG/DL. CUSTOMER ALSO REPORTED THAT BATTERY COMPARTMENT WAS CRACKED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8742944 ↗MalfunctionJun 20, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 228 MG/DL AND 194 MG/DL. THE CUSTOMER REPORTED THAT COULD NOT GET THE ACT BUTTON TO WORK AT ALL. THE CUSTOMER REPORTED THAT THE TIME CLOCK WAS ADVANCING. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE PUMP AND REVERT TO BACKUP PLAN PER HEALTH CARE PROFESSIONAL INSTRUCTIONS. THE CUSTOMER WAS ADVISED THE PUMP WILL NEED TO BE REPLACED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8715717 ↗InjuryApr 16, 2019Excess Flow or Over-Infusion; Excess Flow or Over-Infusion
CUSTOMER CALLED AND REPORTED THAT THEY RECEIVED EMERGENCY MEDICAL ASSISTANCE DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 33 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER WAS AT 220 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER USED FOOD, GLUCOSE TABLETS, AND WAS GIVEN INTRAVENOUS GLUCOSE TO TREAT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS FAINTING. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER BELIEVES THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE CUSTOMER HAD A LOW OF UNDER 20 MG/DL THE NIGHT PRIOR TO THE CALL AND THEY PASSED OUT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hypoglycemia
MAUDE report 8517221 ↗MalfunctionApr 16, 2019Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WAS UNDER DELIVERING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 325, 215 MG/DL. THE CUSTOMER WAS TREATED WITH THE MANUAL INJECTION. THE CUSTOMER ALLEGES INSULIN PUMP WAS UNDER DELIVERING BECAUSE AFTER THE SECOND DAY OF WEARING THE INFUSION SET HER BLOOD GLUCOSE GOES UP. THE CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER WAS NEITHER IN EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL, AS A RESULT OF HIGH BLOOD GLUCOSE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8517176 ↗MalfunctionApr 15, 2019Mechanical Problem; Obstruction of Flow; Battery Problem; Connection Problem; Power Problem; Patient Device Interaction Problem; Mechanical Problem; Obstruction of Flow; Battery Problem; Connection Problem; Power Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEIR INSULIN PUMP WAS DAMAGED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS UNKNOWN AT THE TIME OF THE INCIDENT. CUSTOMER REPORTED RESERVOIR WAS LOOSE AND NOT SECURE AND BATTERY LIFE DIMINISHED AND MAKES SOME GRINDING NOISES DURING REWIND AND NO DELIVERY ALARM.THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE DEVICE WAS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8513379 ↗MalfunctionApr 3, 2019Display or Visual Feedback Problem; Device Difficult to Program or Calibrate; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE THAT THE ACT BUTTON WAS WORN, REDLINE THROUGH SCREEN AND LOUDER DURING REWIND PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS UNKNOWN. INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8476968 ↗InjuryMar 30, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS OVER 400 MG/DL. THE INFUSION SET CANNULA WAS BENT. THE CUSTOMER DID NOT PROVIDE INFORMATION ABOUT SYMPTOMS AND TREATMENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8467759 ↗InjuryMar 26, 2019Obstruction of Flow; Obstruction of Flow
THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH BLOOD GLUCOSE LEVEL. CUSTOMER¿S BLOOD GLUCOSE WAS 450 MG/DL AT THE TIME OF INCIDENT. THE CURRENT BLOOD GLUCOSE LEVEL IS 284 MG/DL. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE WITH INSULIN PUMP AND INJECTIONS. CUSTOMER STATES INSULIN PUMP ALARM NO DELIVERY ALARM. CUSTOMER STATES THE INSULIN DID NOT EXIT AND INSULIN PUMP ALARMED NO DELIVERY. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8450717 ↗MalfunctionMar 13, 2019Device Difficult to Program or Calibrate; Device Difficult to Program or Calibrate
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE B AND UP BUTTON WAS NOT WORKING. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 MG/DL. CUSTOMER WAS ADVISED TO OBSERVE TIME CLOCK FOR ONE MINUTE TO VERIFY IF TIME ADVANCES AND THEY STATED THAT THE TIME WAS ADVANCES. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8415791 ↗InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
THE CUSTOMER¿S MOTHER REPORTED VIA PHONE CALL THAT THEY WERE WENT TO EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE AND DIABETIC KETOACIDOSIS ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 690 MG/DL. THE CUSTOMER'S CURRENT BLOOD GLUCOSE IS 127 MG/DL. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER EXPERIENCED NAUSEA AS A RESULT OF HIGH BLOOD GLUCOSE VALUE. THE CUSTOMER TREATED HIGH BLOOD GLUCOSE VALUE WITH INTRAVENOUS MANUAL INJECTION. THE CUSTOMER REPORTED SMALL BUBBLE. THE CONNECTOR OF THE INSULIN PUMP THERE WAS LEAKING COMING OUT. CUSTOMER WAS UNABLE TO COMPLETE CARELINK UPLOAD. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Elevated Ketones/ Diabetic Ketoacidosis; Hyperglycemia; Nausea
MAUDE report 8346879 ↗MalfunctionJan 17, 2019Obstruction of Flow; Connection Problem; Patient Device Interaction Problem; Obstruction of Flow; Connection Problem; Patient Device Interaction Problem
THE CUSTOMER REPORTED VIA PHONE CALL THAT THE CRACKED RESERVOIR LIP RING FROM RESERVOIR AREA. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. CUSTOMER ALSO REPORTED THAT THE INSULIN PUMP HAD RECEIVED NO DELIVERY ALARM. TROUBLESHOOTING WAS PERFORMED FOR DAMAGE AND NOTICED THE RESERVOIR DID NOT ABLE TO MOVES AROUND. CUSTOMER WAS ADVISED TO THE INSULIN PUMP WILL NEED TO BE REPLACED AND TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8255990 ↗InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER'S PARENT REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS AND HOSPITALIZATION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 477 MG/DL. CUSTOMER EXPERIENCED NAUSEA, VOMITING, FELT THIRST, EXPERIENCED FATIGUE AND TREATED THEIR HIGH BLOOD GLUCOSE LEVELS VIA INSULIN PUMP. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 337 MG/DL. CUSTOMER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 AT 1:00 PM DUE TO HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8049656 ↗InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event
CUSTOMER'S PARENT REPORTED VIA PHONE CALL HIGH BLOOD GLUCOSE LEVELS AND HOSPITALIZATION. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 477 MG/DL. CUSTOMER EXPERIENCED NAUSEA, VOMITING, FELT THIRST, EXPERIENCED FATIGUE AND TREATED THEIR HIGH BLOOD GLUCOSE LEVELS VIA INSULIN PUMP. CUSTOMER¿S CURRENT BLOOD GLUCOSE LEVEL WAS 337 MG/DL. CUSTOMER WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2018 AT 1:00 PM DUE TO HIGH BLOOD GLUCOSE LEVELS. TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE WAS PERFORMED. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: Hyperglycemia
MAUDE report 8049649 ↗MalfunctionOct 8, 2018No Display/Image; No Display/Image
CUSTOMER REPORTED VIA PHONE THAT THE INSULIN PUMP HAD FAILED BATTERY TEST ALARM AND BLANK DISPLAY. CUSTOMER¿S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7942631 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P120010. One submission often covers many models, so check the product and lot details in each record.
- Z-1751-2026 · Feb 13, 2026 · Open, ClassifiedMiniMed 530G Insulin Pump (MMT-551, MMT-751)
- Z-2544-2014 · Mar 13, 2014 · TerminatedMedtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K
Other Artificial pancreas device system, threshold suspend devices
- t:slim X2 Insulin Pump with Basal-IQ 1000886Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall17 deaths108,656 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend4 recalls98 deaths35,170 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000912Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall2 deaths30,219 reports
- t:slim X2 Insulin Pump with Basal-IQ 1000898Tandem Diabetes Care, Inc. · Automated Insulin Dosing , Threshold Suspend1 recall6 deaths16,106 reports
- MiniMed® 630G MMT-1715KMMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls50 deaths9,892 reports
- MiniMed® 630G MMT-1715KMedtronic Minimed, Inc. · Automated insulin dosing , threshold suspend4 recalls36 deaths7,947 reports
- MiniMed® 530G MMT-751NASMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend36 deaths7,479 reports
- MiniMed®630G MMT-1715KMedtronic Minimed, Inc. · Artificial pancreas device system, threshold suspend2 recalls17 deaths6,645 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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